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Exhibit 988

Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format, final rule, 88 Fed. Reg. 80958

Exhibit 988 ยท Regulation

Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format, final rule, 88 Fed. Reg. 80958

This rule is effective May 20, 2024. The compliance date of this rule is November 20, 2024.

Final rule implementing section 901(d)(3) of FDAAA. History section cites the proposed rule of 29 March 2010 (75 FR 15376). Effective 20 May 2024; compliance date 20 November 2024.

Source
U.S. Food and Drug Administration
Date
21 November 2023
Quoted from
DATES
Grade
Primary record
Document
https://www.federalregister.gov/documents/2023/11/21/2023-25428/direct-to-consumer-prescription-drug-advertisements-presentation-of-the-major-statement-in-a-clear
Accessed
2026-11-10
Cited by
Findings citing this exhibit

Cited by

Finding INF-1.8
Primary record FDA issued final guidance on consumer-directed broadcast advertisements in August 1999, after announcing a draft on 12 August 1997. The Food and Drug Administration Amendments Act of 27 September 2007 required FDA to set standards for a clear, conspicuous and neutral major statement in television and radio drug advertisements within 30 months; FDA proposed a rule on 29 March 2010 and published the final rule on 21 November 2023, with compliance required from 20 November 2024.